State Consumer Disputes Redressal Commission
Dr Ramesh Uddav Kulkarni vs Dr Amit P Maydeo on 27 April, 2018
CC/09/03
BEFORE THE HON'BLE STATE CONSUMER DISPUTES REDRESSAL
COMMISSION, MAHARASHTRA, MUMBAI
Complaint Case No. CC/09/03
Dr.Ramesh Uddav Kulkarni
R/o. 4, Uddhav Memorial (Cancer) Hospital,
Adgaon, A/P. Tal. & Dist. Nashik-422 003. ...........Complainant(s)
Versus
Dr.Amit P. Maydeo
Director & Chief Endoscopist Institute of
Advanced Endoscopy, Endoscopy Research
Foundation, Mumbai, 5th floor,
Om Chambers, 123 August Kranti Marg,
Mumbai - 400 036. ............Opponent (s)
BEFORE:
Justice A.P. Bhangale PRESIDENT
Dr.S. K. Kakade MEMBER
For the Complainant present a/w. Advocate
Complainant: Mr.Subodh Gokhale.
For the Dr.G.N.Shenoy, Advocate i/b.Kay Legal &
Opponent: Associates for opponent.
ORDER
Per Dr.S.K. Kakade, Hon'ble Member Complainant has alleged Medical Negligence. The complainant, Dr.Ramesh Kulkarni is a surgeon with M.S. General Surgery qualification and specialist in the field of cancer related treatment. He runs "Uddhav Memorial hospital" at village Adgaon in the district of Nashik, Maharashtra. He has two years' experience of working as resident Surgical Registrar at Tata Memorial Cancer Hospital and Research Centre, Mumbai. The opposite party is Dr.Amit Maydeo, with qualification MS General Surgery and Fellowship in Advanced Endoscopy from Germany, Director and the Chief Endoscopist at the Institute of Advanced Endoscopy, Mumbai.
The complainant has filed a complaint at State Consumer Commission of Maharashtra under section 17 of the Consumer Protection Act, 1986 claiming compensation of Rs.25 Lakhs attributing deficiency in 1 CC/09/03 services and medical negligence in the treatment of the complainant himself.
1. The facts of this case are as follows. In the month of December 2006, the complainant suffered from abdominal pain that was diagnosed to be biliary colic. In April 2006, his silent gallstones were detected that became symptomatic in the month of December. He consulted Dr. Ramesh Patil, consulting surgeon and endoscopist from Nashik on 18th December 2006. As per the advice of Dr. Patil, certain investigations of blood and ultrasonography of abdomen were done. Dr. Patil suspected that in addition to the Gall stones there was some problem with the CBD (Common Bile Duct). As per the advice of Dr. Ramesh Patil, the complainant consulted Dr. Amit P.Maydeo, from Mumbai, who is specialist in endoscopy and biliary treatment.
2. Dr. Amit Maydeo,(opposite party) after consultation on 5/ 1/ 2007, performed EUS (Endoscopic Ultra sonography) + ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure on the complainant at his institute of Advanced endoscopy, Mumbai, but he failed to take informed consent having failed to inform the complainant about the risks involved in the endoscopic treatment with sphincterotomy and stenting. The opposite party detected roundworms in common bile duct. Endoscopically he removed the round worms from the CBD. While doing so he performed wide biliary sphincterotomy and after complete ductal clearance, Zentel suspension was used as drug to clear the roundworms. In addition to the above he also inserted stent of size 10 Fr in the CBD.
The complainant was discharged on the very day of the aforesaid procedure of sphincterotomy and stenting of CBD. Within 12 hours of the said procedure the complainant started getting abdominal pain i.e. from morning of 6 January 2007. The complainant tried to contact the opposite party telephonically, but allegedly there was no response from the opposite party and hence took some local treatment for the abdominal pain. Complainant consulted Dr Ravindra Shivade of Nashik. As per his advice CT scan of abdomen 2 CC/09/03 was done on 15th January 2007. Dr. Vinchurkar, chief radiologist reported that the CBD stent is displaced and seen with upper and in 3/4 part of duodenum extending inferiorly into region of right iliac fossa. Also focal peritonitis / oedema was noted.
3. On Consulting Dr Prakash Joshi, Gastroenterologist from Nashik, he confirmed the findings at CT scan. He contacted Dr. Amit Maydeo who advised that the complainant should get admitted in Jaslok hospital Mumbai for further treatment. The complainant got admitted at Jaslok hospital Mumbai on 16th January 2007. As per the reference by Dr. Maydeo, Dr. K P Balsara operated upon the complainant on 17th January 2007. Exploratory laparotomy was performed. The CBD stent was found to be migrated and perforating third part of the duodenum with localised abscess cavity. In addition to the stent removal and Drainage of the abscess, Dr. K. P. Balsara also performed Cholecystectomy.The complainant submits that, he being diabetic, obese and suffering from heart disease, there was high risk in performing this operation. He was discharged from the Jaslok hospital on 24th January 2007 with abdominal pain, jejunostomy and stiches on.
4. While alleging the medical negligence on the part of the opposite party the complainant submits that the opposite party has not done the correct diagnosis, did not follow pre-operative protocols such as taking informed consent of the patient, doing biochemical and medical investigations, inserted CBD stent when not indicated, did not advise immediate hospitalization / surgery or proper treatment / investigations when excruciating pain was reported within 10 hours of the endoscopic stenting. He further submitted that the opposite party avoided taking phone calls or corresponding with the patient in any manner. The opposite party did not attend the patient immediately after the admission in Jaslok hospital despite being aware of the life-threatening condition of the complainant. Hence the complainant submits that the opposite party is guilty of medical negligence that resulted in pain and suffering by the complainant.
3CC/09/03
5. The opposite party in the written statement opposed the allegation against him and submitted that it was not true that the OP could not be contacted in post endoscopy period. Further submits that stenting was done with world class expertise and according to the standard technique described and practiced all over the world. The stent used was from one of the best companies and there is 5 % inherent risk of displacement of the stent. In his written statement the opposite party raised preliminary objections like non joinder of other doctors who treated the complainant, deliberate non- disclosure of relevant information, deliberately resorting to falsehood to obtain a favourable order, real cause for filing complaint is extortion. He also submits that, not only he has given best international standard treatment, but also submitted expert opinions from noted experts in the same field.
6. Complainant's material and relevant grievance as per his complaint The complainant made reference to the investigations done since beginning and argued that, after the diagnosis of the Gall stones on 17th December 2016, he was referred to Dr. Amit Maydeo for further treatment. On 5th January 2007 Dr. Maydeo performed EUS in which he performed endoscopic wide sphincterotomy of the Papilla in the duodenum, removed the round worms and then placed stent in the CBD of size 10 F. This procedure was done on OPD basis and he was allowed to go to Nashik. He submitted that, for this OPD procedure, his consent was not obtained and he was not explained the complications of the said procedure. For the abdominal pain that started next day of the procedure he tried to contact his doctor telephonically but Dr. Maydeo didn't respond, nor does he call back. So the complainant undertook the treatment locally at Nashik and suffered from abdominal pain for next 10 days , when he was advised CT Scan of abdomen by Dr. Prakash Joshi that showed stent migration along with duodenal perforation and localized abscess behind the duodenum. After contacting Dr. Maydeo by Dr. Prakash Joshi, he advised admission 4 CC/09/03 in Jaslok hospital on 16th Jan 2007. After admission at around 4 p.m., Dr. Maydeo visited the complainant at 8 pm and then referred him to the Surgeon, Dr.K.P. Balsara who in turn visited at 9 pm. His operation was done by Dr.K.P. Balsara next day in evening where findings were migration of the CBD stent and perforation of the duodenum 3rd Part with posterior localized abscess. The stent was removed, abscess cavity drained and cholecystectomy performed, feeding jejunostomy was performed and the cavity was drained by putting a drain. The complainant alleges that Dr.Maydeo purposefully visited him late in Jaslok hospital on 16th Jan. and delayed the surgery for the sake of deposit. He alleged that, as Dr.Maydeo has wrongly performed the endoscopic wide sphincterotomy with metal stenting of the CBD, the stent migrated and he had to suffer and had to undergo the laparotomy. So he alleges that the Opposite party is guilty of negligence by not taking consent and without explaining the risk of stenting, Dr.Maydeo performed in his institute. Also he submitted that the opposite party had unnecessarily performed endoscopic wide sphincterotomy at duodenal papilla and wrongly placed the CBD stent that migrated caused duodenal perforation that resulted in laparotomy surgery immediate after the first procedure of endoscopic treatment.
The complainant has demanded the following compensation for his mental, physical and financial suffering.
1. Jaslok Hospital Bill Rs.2,59, 428 /-
2. Expenses towards postoperative Rs. 50,000/-
drugs, medicines etc
3. Loss of Income during the period Rs. 1,50,000/-
of operation & post operation rest for 3 months
4. Towards compensation for Rs. 20,00,000/-
mental agony, harassment, hardship, loss of future income, loss of health, stamina & capacity to work, pains & sufferings 5 CC/09/03
5. Towards expenses for filing Rs. 50,572/-
complaint, advocates fees etc. Total Rs.25,00,000 /-
7. Respondent's Version about his response to the complainant's grievance The opposite party admitted that he examined the complainant on 5th of January 2007, in his Institute and found him to be complaining of pain in the abdomen and also had symptoms of cholangitis. He decided to perform endoscopic ultrasonography and ERCP. He submits that after taking an informed consent and explaining all the risks and complications of the interventional ERCP procedure, he performed the same. After finding roundworms in the CBD heated sprinter autonomy and removed roundworms. Also he used Zentel suspension to paralyze other ones. He also submits that in spite of the advice, complainant didn't get admitted as he was surgeon himself.
After receiving the information from Dr Prakash Joshi, senior consultant Gastroenterologist of Nashik on 15th January 2007, advised the complainant to get admitted in Jaslok Hospital Mumbai. The complainant got admitted in Jaslok hospital on 16th January at around 4 p.m. Opposite party visited and examined the complainant at around 8:30 p.m., then made reference to the surgeon Dr. Balsara, in turn visited and examined the complainant at around 9 p.m. The complainant was operated by Dr.Balsara on next day evening. He removed the displaced stent, drained localised abscess cavity, performed cholecystectomy and jejunostomy. After uneventful stay in the hospital the complainant was discharged on 24th January 2007.
The opposite party submits that there was no negligence or rashness on his part and he has not violated treatment protocol while treating the complainant. He also submits, there are inherent risks of stenting procedure and migration of the stent was purely accidental. He mentions that difference of opinion / errors in diagnosis is not negligence when proper application of mind is present.
6CC/09/03 The opposite party vehemently summits that there was contributory negligence on the part of the complainant; he did not attend to my call stones since 2006 after its diagnosis. The complainant delayed the consultation with opposite party by 18 days and postoperatively left Hospital against medical advice are the grounds for the contributory negligence by the complainant.
8. As per the request from State Consumer Disputes Redressal Commission Maharashtra there was submission of report from the expert medical committee of Sir JJ group of hospitals. It is signed by the head of department of surgery, lecturer in surgery and resident medical officer. The conclusion of the report reads as under-
"taking into consideration about finding prima facie there is no negligence in the treatment of complainant".
In the light of the above discussion, in the present case we have heard the complainant and the learned advocate of opposite party and perused the record. Considering the rival contentions of the parties, considering the record and keeping in view the scope of the complaint, following points arise for our determination and our findings there on are noted for the reasons as below -
Points
Sr.No Points Findings
1 Whether the complainant proves the Yes
medical negligence by the opposite party
in treating him?
Medical Negligence and 'Deficiency in
service' in the following
A. Diagnosis? No
B. Obtaining written as well as Yes
Informed Consent?
C. Actual endoscopic Procedure? No
D. Negligence in Postoperative Care? Partly yes
2 Whether the complainant proves that Yes
there is deficiency in service on the part
of opposite party?
7
CC/09/03
3. Whether the opposite party proves that No
there was contributory negligence by the
complainant?
4. Whether complainant is entitled for As per final
compensation as claimed? Order
5. What order? Complaint is
partly allowed
Discussion:
9. We have gone through the documents on record - complaint memo, written statement, expert opinions, and written notes of arguments by parties, medical literature and the case laws submitted by both the parties. The exhaustive list of medical literature and the case laws is as follows-
Medical Literature submitted on record
1. Bailey and Love's Short Practice of Surgery- Diseases of Liver and Biliary Tract
2. API Text Book of Medicine- Diseases of Gall Bladder and Biliary Tract
3. World Journal of Gastroenterology- 2007
4. Hepatobiliary Pancreat Dis Int No.6 Dec.2008
5. HPB 2003 Volume 5, Number 3.
6. Gastrointestinal Endoscopy Vol. 50, No.1 1999
7. Postgrad Med. 2000 Case Laws referred By Opposite Party
1. Kusum Sharma Vs. Batra Hospital & Medical Research Centre 2010 (4) Mh.L.J. 541
2. Hatcher Vs.Black ( 1954)
3. Jacob Mathew Vs. State of Punjab & Anr 2005 (3) CPR 70 (SC)
4. RamjilalVs.Sarvodaya Medical 2542 Consumer 1986-1996, FA No.4/93 NCDRC, decided 17th Feb.1995 8 CC/09/03
5. Dilip Narayan BhelandeVs.Dr.PrakashP.Pant : CC/13/1990
6. DCM Datta Products Vs.Hanuman Prasad Podar Hospital Gorakhpur , 1986-1995 Consumer 290 (NC)
7. SP Chengalvaraya Naidu ( by LRS)Vs. Jagannath (by LRS), AIR 1994 Supreme Court 853 By Complainant
8. V.Kishan Rao Vs. Nikhil Super specialty Hospital & Anr, 2010 (1) CPR 1 ( NC)
9. Umakant Kisan Mane Vs. Dean, Rajawadi Municipal hospital, WP No.431 of 2003, Bombay High Court, decided on 21st December 2015.
10. Shri.P.G.Pai Vs. Care Elevators& Engineering Co.Pvt.Ltd. CC/15/2006, decided on 7th January 2015
11. Manoharan L.Devangan Vs.Dr.VinitaGoyal& Ors, CC/02/261 Mah.Consumer Disputes Redressal Commission, Mumbai, decided on 11th February 2015.
12. FA No.117 of 2007 NCDRC
13. Samira Kohli Vs.Prabha Manchanda & Anr- Appeal ( Civil) 1949 of 2004.Decided 16th January 2008.Supreme Court, (2008) 2 SCC 1.
14. Nizam's Institute of Medical Sciences Vs. Prashanth S.Dhanaka- CA No.4119 of 1999 and 3126 of 2000, Supreme Court decided on 14th May 2009.
After going through the judgments, it is to be noted that the ratios laid down by Honourable Supreme Court and the National Consumer Disputes Redressal Commission on the point of medical negligence are binding on all the consumer courts. We also rely on certain relevant and important findings of these case laws.
10. In Kusum Sharma and Ors Vs.Batra Hospital and Research Centre and Ors, the principles have been laid down as follows
94. On scrutiny of the leading cases of medical negligence both in our country and other countries especially United Kingdom, some basic principles emerge in dealing with the cases of medical negligence. While deciding whether the medical professional is guilty of medical negligence following well known principles must be kept in view:-
9CC/09/03 I. Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.
II. Negligence is an essential ingredient of the offence. The negligence to be established by the prosecution must be culpable or gross and not the negligence merely based upon an error of judgment. III. The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires. IV. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field. V. In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of other professional doctor. VI. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Just because professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence.
VII. Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession.
VIII. It would not be conducive to the efficiency of the medical profession if no Doctor could administer medicine without a halter round his neck. IX. It is our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessary harassed or humiliated so that they can perform their professional duties without fear and apprehension. X. The medical practitioners at times also have to be saved from such a class of complainants who use criminal process as a tool for pressurizing the medical professionals/hospitals particularly private hospitals or clinics for extracting uncalled for compensation. Such malicious proceedings deserve to be discarded against the medical practitioners. XI. The medical professionals are entitled to get protection so long as they perform their duties with reasonable skill and competence and in the interest of the patients. The interest and welfare of the patients have to be paramount for the medical professionals.10
CC/09/03
11. The concept of medical negligence is being dealt with settled principles of the law that govern it. Reasonable degree of care and skill means that the degree of care and competence that an "ordinary competent member of the profession who professes to have those skills would exercise in the circumstance in question."
The burden of proof is correspondingly greater on the person who alleges negligence against a doctor than a charge of negligence against the driver of motor car.
12. The Hon'ble Supreme Court in the landmark case of Dr. Laxman Balkrishna Joshi vs. Dr. Trimbak Bapu Godbole, AIR 1969 SC 128, has held that with the best skill in the world, things sometimes go wrong in medical treatment or surgical operation. A doctor cannot be blamed to be negligent simply because something goes wrong or someone else of better skill or knowledge would have prescribed a different treatment or operated in a different way. In the landmark judgment of Indian Medical Association vs. V.P.Shantha, the Apex Court has decided that the skill of a medical practitioner differs from doctor to doctor and it is incumbent upon the Complainant to prove that a doctor was negligent in the line of treatment that resulted in the life of the patient. It is for the Complainant to prove the negligence or deficiency in service by adducing expert evidence or opinion and this fact is to be proved beyond all reasonable doubts.
13. As regards medical negligence, the Hon'ble Supreme Court in Jacob Matthew Vs. State of Punjab & Anr.III (2005) CPJ 9 (SC) "(3) A professional may be held liable for negligence on one of the two findings; either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the 11 CC/09/03 highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence".
14. The liability of a doctor arises not when the patient has suffered any injury, when he is treated in good faith but when the injury has resulted due to the conduct of the doctor, which has fallen below that of reasonable care. Thus, the doctor is not liable for every injury suffered by a patient. He is liable for only those that are a consequence of a breach of his duty. Hence, once the existence of a duty has been established, the complainant must still prove the breach of duty and the causation. In case there is no breach or the breach did not cause the damage, the doctor will not be liable. In order to show the breach of duty, the burden on the complainant would be to first show what is considered as reasonable under those circumstances and then that the conduct of the doctor was below this degree.
Therefore keeping the law laid down by Hon'ble Supreme Court and the principles of medical negligence in mind hereby the present facts and the evidence before us in the present case are assessed.
Reasons The point No.1 & 2 are interlinked with each other, hence are discussed as follows:
15.As to the Point No.1 (Negligence in the Diagnosis and Endoscopic treatment) (Discussed 1 A and 1 C together) The complainant approached the opposite party after his gallstones became symptomatic. This is an undisputed fact that, the opposite party performed endoscopic ultrasonography and ERCP on the complainant. During the endoscopy the opposite party decided to 12 CC/09/03 proceed ahead with wide sphincterotomy and stenting of the CBD; after clearing of the CBD of the roundworms. The complainant submitted that the size of CBD was 10 mm and there was less possibility of escape of any gall stone from the Call bladder into the CBD, the opposite party was negligent in performing wide sphincterotomy and stenting of the CBD. He specifically stressed that putting the metal stent in the CBD when not indicated was gross negligence. The opposite party on the other hand opposed this contention and submitted that he has followed accepted practice with International standard. Putting off metal stent in the CBD was necessary to prevent the CBD obstruction from gallstones.Both parties have submitted expert opinions in support of their contention.
The complainant submitted the expert opinion on Dr. Shobha Nerlikar, consultant surgeon from Nashik, to give her opinion as, "in absence of pathology of common bile duct, the placement of the stent in CBD is not only unnecessary but dangerous as there is no support to the stent after wide sphincterotomy. In this case, due to this mistake, the stent migrated and caused perforation of the duodenum."
16. The opposite party submitted the expert opinions of 4 experts from this field.
Dr. D. Nageshwar Reddy, Endoscopic surgeon from Asian Institute of Gastroenterology, Hyderabad opined that the complainant was correctly managed by the opposite party. And the displacement of stent is not negligence or deficiency in service by the opposite party. He mentions that there is documented risk of displacement of stents in about 5% of the cases.
Dr.Tehemton E. Udwadia, Endoscopic surgeon from Mumbai with 40 years of experience opined that the stents are known to displace and migrate even when put by the best of the hands, in the best of the centres all over the world. In the instant case the stent was used was made of special design to reduce the chances 13 CC/09/03 of slippage or displacement with its "Christmas tree" like side flaps. Hence he submitted that the complainant was correctly treated by the opposite party.
Dr.Dhiren H. Pipalia, Endoscopic surgeon from Mumbai, submits that he has experience of performing a lot of ERCP with wide sphincterotomy and stent Placement in cases of biliary ascariasis. He categorically stated that placing a Tannenbaum stent after a sphincterotomy is a standard accepted practice followed by the Endoscopists all over the world and the opposite party cannot be branded as negligent.
Dr.Roy Sunil Patankar, General and endoscopic surgeon from Mumbai with experience more than 17 years, opined that stones are known to slip down from the gallbladder before cholecystectomy is done and this can cause common bile duct obstruction. A stent is placed after the sphincterotomy as a routine practice in most endoscopy centre of the world. He says that the complainant was correctly treated by the opposite party.
The interrogatories were exchanged by both the sides in lieu of cross examination to all the experts and also to the complainant and the opposite party themselves to which the replies were filed by both sides to explain the technical details. Perused all the record, which supported the answer given to the point no.1.
17. We have also perused the report submitted by the expert committee of sir JJ group of hospitals which subject as expert opinion on medical negligence. After going through the papers made available to the expert committee, it concluded that duodenal perforation after ERCP is known complication. With reference to the article by Peter B Cotton the rate of duodenal perforation is 0.1%. There are no comments on the correctness of endoscopic wide sphincterotomy with CBD stenting in case of round worm infestation, which is the point of dispute. But the report ends with "prima facie there is no negligence in treatment 14 CC/09/03 of complainant".
Both the parties and Experts have placed on record voluminous medical literature that includes chapters from various surgical and medical books, case reports, and articles from renowned journals in the field of specialty.
The complainant has relied on the judgments of the following cases on the point of the doctrine of Res Ipsa Loquitor.
1. V.Kishan Rao Vs. Nikhil Super specialty Hospital-Supreme Court (Supra)
2. Umakant Mane Vs. Bombay Municipal Corporation - Bombay High Court (Supra)
3. P.G.Pai Vs.Care Elevators - NCDRC (Supra)
4. Mr.Manharan Lal Dewangan Vs. Dr.Vinita Goyal & Ors.- SCDRC (Supra) After going through these judgments and the ratios, we find that the doctrine of Res Ipsa Loquitor cannot be applied to the instant case.
18. We are of the opinion that the correctness of the treatment of the complainant in respect of diagnosis and the actual endoscopic procedure is the matter of subject experts. We find that they are expert opinions with views contrary to each other. The court need not decide the correctness of the treatment when different schools of thought advise different lines of treatment. The court will not endorse any one line of treatment. And hence based on the pleadings, evidence placed on record and the submissions of both parties, we find that there is no negligence by the opposite party in the treatment of the complainant in respect of diagnosis and endoscopic procedure.
19.As to the Point No.2 ( Deficiency in Service) (Discussed 1 B and 1 D together with this point no.2) The complainant submits that before performing endoscopy at the endoscopy centre of the opposite party and further treatment, the written consent was not taken. At the same time the opposite party did not explain the risk of the endoscopic treatment 15 CC/09/03 especially wide sphincterotomy with stenting of CBD. In the written arguments, the complainant alleges that there was a failure to comply with preoperative protocol by the opposite party. The opposite party conducted the invasive procedures after ERCP like wide sphincterotomy followed by CBD stenting without taking informed consent. As the complainant was suffering from diabetes, blood pressure heart disease, obesity etc., he was high risk patient. However risks in endoscopic procedures where not explained to him. The possible complication like Migration of stent and possibility of duodenal perforation was not explained. The complainant also alleges but there was no proper follow up care by the opposite party. Anticipating the stent migration the opposite party could have advised medical investigations or admission in Jaslok hospital for further care, when the complainant informed about his symptoms to the opposite party on 10th January 2007. The complainant alleges that the opposite party did not respond to his phone calls while he tried to contact for seeking his help in treating his symptoms.
20. The opposite party vehemently denied that he did not respond to the complainants phone calls. The opposite party mention that the telephone numbers of the Institute of Advanced endoscopy are mentioned on the file and this is a roaming number with 10 lines. In addition the email address of the opposite party is printed on the file. It is not possible that for 10 days the complainant could not contact opposite party or even send an email stating urgency of the matter. He also submitted that the post ERCP issues are not due to deficiency in services but was due to ailment suffered.
21. The learned advocate for the opposite party submitted that the written consent of the complainant patient was not obtained as he himself is surgeon and understands all aspects of Surgical Management. As endoscopic treatment was carried out on OPD basis, it was done under sedation and hence implied consent was considered. The written statement of the opposite party mentions that on "5th January 2007 OP did an ERCP on the complainant after 16 CC/09/03 taking an informed consent and explaining all the risks and complications of the interventional ERCP procedure". The learned advocate of the opposite party informed the court that in the instant case the cause of action arose in 2007; there was no concept called informed consent at that time. The concept of informed consent was discussed and implemented in the "Samira Kohli" Judgment that was pronounced by the Honourable Supreme Court in 2009. Also the learned Advocate admitted that there is no document on record giving details of the consent and the OPD procedure carried out at Institute of Advanced endoscopy by the opposite party. The learned advocate also admitted that the record of OPD procedure is not maintained and hence it is not on record.
22. We are guided by the "Samira Kohli" Judgment on Informed Consent by Hon'ble Supreme Court, the relevant Para are as follows-
Para 17 Unless the unauthorized additional or further procedure is necessary in order to save the life or preserve the health of the patient and it would be unreasonable ( As construed from being inconvenient) to delay the further procedure until the patient regains consciousness and takes a decision, a doctor cannot perform such procedure without the consent of the patient.
Para 18 We may also refer to the code of medical ethics laid down by the Medical Council of India (approved by the Central Government under section 33 of Indian Medical Council Act, 1956). It contains a chapter relating to disciplinary action which enumerates a list of responsibilities, violation of which will be professional misconduct. Clause 13 of the said chapter places the following responsibility on a doctor:
"13. Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian 17 CC/09/03 in the case of a minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed."
Para 19 We therefore hold that in Medical Law, where a surgeon is consulted by a patient, and consent of the patient is taken for diagnostic procedure/surgery, such consent cannot be considered as authorisation or permission to perform therapeutic surgery either conservative or radical (except in life threatening or emergent situations). Similarly where the consent by the patient is for a particular operative surgery, it cannot be treated as consent for an unauthorized additional procedure involving removal of an organ, only on the ground that such removal is beneficial to the patient or is likely to prevent some danger developing in future, where there is no imminent danger to the life or health of the patient.
Para 20 We may next consider the nature of information that is required to be furnished by a Doctor to secure a valid or real consent. In Bowater v. Rowley Regis Corporation - [1944] 1 KB 476, Scott L.J. observed: "A man cannot be said to be truly 'willing' unless he is in a position to choose freely, and freedom of choice predicates, not only full knowledge of the circumstances on which the exercise of choice is conditioned, so that he may be able to choose wisely, but the absence from his mind of any feeling of constraint so that nothing shall interfere with the freedom of his will." Samira Kohli vs. Dr. Prabha Manchanda & Anr on 16 January, 2008
23. The consent is perhaps the only principle that runs through all aspects of Healthcare provisions today. It also represents the legal and ethical expression of the basic right to have one's autonomy and self-determination. If a medical professional treats a patient without valid consent, then he will be liable under both tort and criminal law. Consent may be inferred from the general submission 18 CC/09/03 by a patient to orders given by a doctor during clinical diagnosis. This is an excellent example of implied consent. If there is indeed to undergo an invasive examination such as an incision on the body; written consent of the patient is ideally required.
24. The Medical Council of India MCI has laid down guidelines issued as regulations (2002) in which consent is required to be taken in writing before performing an operation. For the treatments other than operations, following may be noted as general guidelines
1. For routine types of treatment, implied consent would suffice.
2. For detailed types of treatment ideal express oral consent may be needed.
3. For Complex types of treatment, written express consent is required
25. Article 21 of the constitution, "Right to Life" enshrines the right to health to the average Indian. The principle of consent also gives right of autonomy to the patient and so he has every right to make informed decisions / choices based on the information provided by the Healthcare service provider. In the instant case the opposite party had not informed the complainant about the possibility of endoscopic wide sphincterotomy with CBD stenting before proceeding for the same.
26. Postoperative Care: In view of these facts and principles laid down by the Indian Medical Council and Honourable Supreme Court, the postoperative care should consist of the following instructions to the patient:
A. Do's B. Don'ts C. Diet D. Medicines E. Special Instructions In the instant case there is deficiency in postoperative care and no instructions were given to the complainant regarding the 19 CC/09/03 above parameters.
27. After going through on the record and sharing the submissions of the complainant and the learnt advocate for the opposite party, we are of the opinion that there is deficiency in service provided by the opposite party. The opposite party failed to deliver reasonable care to the complainant by not taking the consent in writing for the invasive procedure he carried out. Performance of such invasive procedure was an unauthorized invasion and interference with the complainant's body which amounted to a tortious act of assault and battery and therefor deficiency in service. Also, he has not documented the communication to the complainant about the information about likely complications and hence did not instruct the complainant regarding likely possibility of the displacement of the stent and further plan of management of such complication. Hence we answer to the points number 1 (b), 1 (d) and 2 as affirmative.
28.As to the Point No.3 ( Contributory Negligence) The opposite party submits in written notes of argument that there was contributory negligence on the part of the complainant which is as follows,
1. He did not attend to his gallstones since 2006 when they were identified.
2. He delayed coming to OP in January 2007 for around 18 days.
3. He left the hospital postoperatively against medical advice and decided to do the post procedure himself.
Heard the submissions made by the complainant and the learned advocate of the opposite party, perused the record. There is no document on record suggesting that there was contributory negligence by the complainant. Hence we answer the point number 3 as negative.
29. Our attention was drawn by the learned advocate for the opposite party to the certificate of Dr.K.P.Balasara issued to the complainant 20 CC/09/03 on 19th December 2008, based on which the complainant has made out the case. He submitted that, the said certificate bears forged signature of Dr.Balsara and thus the complaint itself is not maintainable. Dr.Balsara had submitted an affidavit dated 10th April 2012, denying the signature on the same certificate. The learned advocate for the opposite party also informed that, the Opposite party filed an FIR No.102 of 2013 at Gavdevi Police station on 11th April 2013. It was not clear why Dr.Balsara did not file the FIR when his signature was forged. After perusal of the record, we have found that, Dr.Balsara had submitted an affidavit on record on 11th Sept.2009, narrating the treatment of the complainant. Surprisingly the contents of the affidavit are exactly same as that of the certificate with his alleged forged signature dated 19th December and the FIR was lodged almost one year after his affidavit declaring the signature to be forged. We are of the opinion that the said certificate does not affect the merit of the case.
30. Also our attention was drawn by the learned advocate of the opposite party to the additional information submitted by the op about the character of the complainant. The opposite party has filed the judgement of Civil Miscellaneous Application No.97 of 1987, denying custody of the child to the father, the complainant in the instant case. There is a discussion on the character of the complainant describing him addict and womanizer. We are of the opinion that such kind of information about the complainant is not only irrelevant in the instant case but also an attempt to divert attention of the court from the merit of the case.
31.As to the Point No.4 ( Compensation) As per the final order.
32.Principles/ guidelines In consonance the regulations of the Indian Medical Council, the guidelines required to be followed by medical professionals are summed up as follows 21 CC/09/03 A. Pre-operative consent for OPD surgical procedures is essential. As per the guidelines of any surgical intervention that involves risk of complications, even though minor and OPD procedure, consent of the patient is important. Absence of which is considered as "act of omission - negligence".
Section 7.16 Indian Medical Council of ethics regulations, 2002, states that," before performing an operation on the patient, the doctor should obtain in writing the consent from patient himself or the husband or wife, as the case may be."
B. The informed consent of the patient is necessary for any OPD or IPD surgical procedure.
C. Since the legal duty of medical professional starts with patient consultation, the same includes preoperative and postoperative care and formal communication with patient with documentary proof of the same.
D. Legal duty also includes post-surgical procedure care of the patient. Foreseeing the known complication and taking steps proactively to avoid as well as treat any complication is also part of "duty of care" by the medical professional.
33.As to the Point No. 5 (What Order?) In view of the answers of Point no. 1 to 4, the complaint deserves to be allowed partly. Hence we pass the following order:-
ORDER
1. Consumer Complaint is partly allowed with costs of Rs.50,000/-
(Rupees Fifty Thousand only) to be paid by the opposite party to the complainant.
2. It is hereby declared that, the opposite party has indulged in deficiency of service while giving endoscopic treatment to the complainant.
3. The opposite party is directed to pay Rs.2,59,428/- (Rupees Two 22 CC/09/03 Lakhs Fifty nine thousand four hundred twenty eight only) towards Jaslok hospital bills for the operation on 17th Jan 2007, with rate of interest @ 9% p.a. from the date of Operation, within 3 months failing which the amount shall carry interest @ 12% p.a. from the date of this order till realization.
4. The opposite party is also directed to pay to the complainant, Rs.10,00,000/- (Rupees Ten Lakhs only) towards compensation for loss of income, pain, suffering and mental agony within 3 months from the date of this order. In case of default, the amount will carry interest at the rate of 12% per annum from the date of order till realization.
Certified copies of this order be furnished to the parties free of cost.
Pronounced Dated 27th April 2018.
[ Justice A.P. Bhangale ] PRESIDENT [ Dr.S. K. Kakade ] MEMBER 23